The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

NCT05742724 | Active Not Recruiting Phase 1

• 1 other identifier: POT_GFR_PK_001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

Conditions

Cannabis; Chronic Kidney Diseases; Dialysis

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (18)

• Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)

  Maximum concentration (Cmax)

  48 hours

• Tetrahydrocannabinol and its metabolites time to Cmax

  Time to Cmax

  48 hours

• Tetrahydrocannabinol and its metabolites last detection time

  Last detection time

  48 hours

• Tetrahydrocannabinol and its metabolites area under the curve

  Area under the curve

  48 hours

• Tetrahydrocannabinol and its metabolites renal clearance

  Renal clearance

  48 hours

• Tetrahydrocannabinol and its metabolites dialytic clearance

  Dialytic clearance

  48 hours

• Cannabidiol and its metabolites maximum concentration (Cmax)

  Maximum concentration (Cmax)

  48 hours

• Cannabidiol and its metabolites time to Cmax

  Time to Cmax

  48 hours

• Cannabidiol and its metabolites last detection time

  Last detection time

  48 hours

• Cannabidiol and its metabolites area under the curve

  Area under the curve

  48 hours

• Cannabidiol and its metabolites renal clearance

  Renal clearance

  48 hours

• Cannabidiol and its metabolites dialytic clearance

  Dialytic clearance

  48 hours

• Other cannabinoids and their metabolites maximum concentration (Cmax)

  Maximum concentration (Cmax)

  48 hours

• Other cannabinoids and their metabolites time to Cmax

  Time to Cmax

  48 hours

• Other cannabinoids and their metabolites last detection time

  Last detection time

  48 hours

• Other cannabinoids and their metabolites area under the curve

  Area under the curve

  48 hours

• Other cannabinoids and their metabolites renal clearance

  Renal clearance

  48 hours

• Other cannabinoids and their metabolites dialytic clearance

  Dialytic clearance

  48 hours

Secondary Outcomes (3)

• Adverse events

  48 hours

• Blood pressure

  48 hours

• Heart rate

  48 hours

Study Arms (1)

THC/CBD

EXPERIMENTAL

Oral THC 0.1mg/kg and CBD 2.5mg/kg

Drug: Tetrahydrocannabinol-Cannabidiol Combination

Interventions

Tetrahydrocannabinol-Cannabidiol Combination DRUG

Oral THC 0.1mg/kg and CBD 2.5mg/kg

THC/CBD

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult age\>25 years
• estimated glomerular filtration rate (eGFR)\>60ml/min/1.73m2 or eGFR\<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated \>90 days
• agree to take the medication as directed in the study
• provides informed consent

You may not qualify if:

• body mass index \<20 or \>35kg/m2
• physical dependence on any drug other than caffeine or nicotine
• history of clinically significant adverse event associated with cannabis intoxication
• history of psychosis or mania or any active major psychiatric disorder
• recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
• taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)
• evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5)
• pregnant or breastfeeding women
• change in ideal body weight or dry weight in the last 4 weeks
• intradialytic hypotension (systolic blood pressure\<90mmHg) requiring an intervention in the previous 4 weeks

Sponsors & Collaborators

• McMaster University: lead
• Center for Medicinal Cannabis Research: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8S 4A6, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse; Renal Insufficiency, Chronic

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Walsh, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 24, 2023
• Study Start: January 11, 2024
• Primary Completion: February 16, 2024
• Study Completion: March 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)